MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM XL HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: comprehensive reevrs tray # 115370 lot # 418310.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 06139.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted.

Event Description

It is reported that during the surgery, the humeral tray and bearing would not snap together.There were no complications in the surgery with the patient but was delayed by 20 minutes.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay that: the information provided on this form was previously submitted under manufacturing report number 0001825034-2017-06990.

• Brand Name: ARCOM XL HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6788037
• MDR Text Key: 83134714
• Report Number: 0001825034-2017-06133
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/20/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 927520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 68 YR